Tue, 21 Nov 2017

Impurity Profiling for Donepzil Hydrochloride Tablet Formulations and Characterisation of Potential Degradant

P. Sreelatha1*, D. Vivekananda Reddy2, Sripal Reddy Palavai1,2 and B. Rama Devi1

1.Department of Chemistry, Jawaharlal Nehru Technological University Hyderabad, College of Engineering, Kukatpally, Hyderabad (T.S), India - 500085.

2.Aurobindo Pharma USA, Inc. Raleigh, North Carolina, USA- 27606.


ABSTRACT

Compendia methods from the USP (United States pharmacopoeia) are widely used in Pharmaceutical drug product testing. However USP methods are under uninterrupted revision to improvement. Donepezil USP monograph is having two methods to quantify donepezil Related substance. The present research work is a single, simple and economic stability indicating impurity profiling method has been developed for scrutiny of Donepezil hydrochloride. Successfully Chromatographic separation has been achieved on an Inertsil C8 3v (150mm x 4.6mm) 3μm with buffered mobile phase consisting of solvent A (mixture of 0.1M phosphate (pH 2.8) buffer and methanol in the ratio 90: 10 (v/v); respectively) and Solvent B (mixture of 0.1 molar (M) phosphate ( pH 2.8) buffer , Acetonitrile and methanol in the ratio 20:20: 60 (v/v); respectively) delivered at flow rate of 1.0 mL/min and the detection wavelength is 215 nm. The drug was subjected to the stress conditions. Donepezil hydrochloride was found to deteriorate significantly in basic, oxidative stress conditions and stable other degradation conditions. One degradant was observed in the stability studies, Which is crossing Identification threshold .the same was isolated and structural elucidation was carried out by H-NMR, Mass spectroscopy. The developed method was corroborated as per ICH guidelines.

Keywords: Impurity profile, Stability indicating, Development, HPLC, Mass spectroscopy, Impurities.


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